Good day, and welcome to the Beyond Air First Quarter 2021 Earnings Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Corey Davis. Please go ahead, sir..

Thank you, Sierra. Good morning, everyone. Thanks for participating in today's conference call for the company's first quarter of fiscal 2021. Leading the call will be Steve Lisi, Chairman of the Board and Chief Executive Officer of Beyond Air.

Joining him will be Douglas Beck, Chief Financial Officer; and Amir Avniel, President and Chief Operating Officer. This morning, Beyond Air issued a press release announcing the financial results of its first quarter of fiscal '21. A copy of the release can be found on the Investor Relations section of the company's website.

Before we begin, I would like to remind everyone that comments and various remarks about future expectations, plans and prospect constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995.

Beyond Air cautions that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated.

Beyond Air encourages you to review the company's filings with the SEC, including, without limitation, the company's Form 10-K, which identify specific factors that may cause the actual results or events to differ materially from those described in the forward-looking statements.

As a reminder, this conference call is being recorded and will be available for audio rebroadcast on the Beyond Air's website. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, August 6, 2020.

Beyond Air undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. So with that, I would now like to turn the call over to Steve Lisi, Chairman of the Board and Chief Executive Officer of Beyond Air.

Steve?.

Thanks, Corey. Good morning, everyone. Thank you for joining us today. Considering we just had our fourth quarter call six weeks ago, I'll be brief. Today, we'll provide an update on our programs and upcoming milestones, after which, I will hand the call over to Doug to provide a review of our financial results.

I will start today's call discussing the concept that is Beyond Air. As I look across our development pipeline, I see so many reasons to be excited about the benefits we offer patients and health care providers as well as the opportunity for us to build shareholder value.

At the core of our story is our system's ability to generate nitric oxide from ambient air, on demand, with just the power from a standard electric outlet.

The capability to generate NO from ambient air enables our devices to have a number of practical features that allow us to address a broad number of complex indications and also have a number of potential advantages in real-world settings compared to cylinder-based legacy systems currently in the market.

The reason I wanted to start today's call highlighting this point is to emphasize the importance of our guidance today that we expect to file the U.S. premarket approval, or PMA, for the LungFit PH to treat persistent pulmonary hypertension of a newborn, or PPHN, to the FDA at the end of next month.

This PMA will set us up for what we expect to be our first FDA approval and subsequent commercial launch of our LungFit platform technology. As I have mentioned in the past, we believe our system has the potential to disrupt the current NO supply chain to hospitals and eventually make the cylinder-based delivery system a thing of the past.

With that said, let me now get into specific programs, starting with LungFit PH. As a reminder, the LungFit PH ventilator compatible system is currently being developed to address PPHN and also for certain cardiac surgery patients outside the United States.

This continues to be our lead program and consumes the vast majority of our engineering, regulatory and quality teams' focus. As I just mentioned, we are in the process of preparing our PMA submission.

I am certain that many of you who follow us closely are aware that PMA submission time line has been delayed by several months due to the COVID-19 pandemic impacting supply chains and logistics for testing.

While we are confident in our filing guidance based on our current situation, we are not in complete control of this time line given the overall macro environment in the U.S. today. I would like to emphasize that under the current circumstances, a delay of only a few months is an outstanding accomplishment for the Beyond Air team.

Given the FDA guidelines for a 180-day review period for PMA, we anticipate the U.S. commercial launch could occur in the second quarter of 2021. Commercial launches outside the U.S. will be dependent on our ongoing partnering discussions and approval time lines in each jurisdiction.

I would like to briefly highlight again the operational, safety and cost advantages of our LungFit PH system over cylinder-based systems. Eliminating cylinders provides the hospital with instant savings on space inventory requirements, training, employee time, patient time in the ICU and safety for both the patient and medical staff.

For obvious reasons, we do not require a nitric oxide manufacturing facility or....

It seems we're having some technical difficulties. Please hold..

Sorry for that break in the call. I'm sure most of you who were in New York hear that there's a lot of damage from the recent storm. So we had power out in a lot of different places, so we're in the middle of that. So I think there was a little bit of a problem with that issue here, so bear with us.

At least it's not happening in Madison, Wisconsin where we're doing our PMA work. So it's a good thing. So maybe get back to where we were.

We were saying we don't require a nitric oxide manufacturing facility or cylinder distribution infrastructure, and these advantages will position Beyond Air to make significant -- take significant share of this market, which is estimated to be more than $300 million in the U.S. and more than $600 million worldwide. Turning to our COVID-19 program.

As we have previously announced, the U.S. COVID-19 study started enrolling the patients in June. To date, the study has shown an excellent safety profile for patients treated with nitric oxide. We anticipate the conclusion of this study within the next 60 days. As a reminder, the U.S.

trial is an open-label study of up to 20 adult patients hospitalized with COVID-19. Subjects are being randomized 1:1 and treated with intermittent dosing using 80 parts per million nitric oxide administered over 40 minutes four times a day, in addition to standard supportive therapy or treated with standard supportive therapy alone.

This lower dose of 80 parts per million is designed to prove the safety of this concentration before moving to a higher concentration that we expect is going to have a more optimal efficacy profile. Primary endpoint is time to clinical deterioration. Other endpoints include reduction in viral load and safety in various biomarkers.

We see a significant opportunity to use the LungFit system in mild-to-moderate patients diagnosed with COVID-19 caused by SARS-CoV-2.

Considering the data compiled to date with high-concentration NO, most notably, the three completed pilot clinical studies in bronchiolitis where infants were hospitalized due to viral infections, we believe that this system could be a significant tool in the battle against this coronavirus.

Staying with the viral lung infection theme, our bronchiolitis program has produced stellar efficacy and safety data to date. As I have previously mentioned, this program is on hold until the pandemic subsides. I'll give a quick review of the data presented to date, which lends support for our chances of success in COVID-19 patients.

Last quarter, we announced positive top line results from our third and final pilot study in bronchiolitis patients, which showed, on an intent-to-treat basis, that 150 parts per million nitric oxide were statistically significant when compared to both 85 parts per million nitric oxide and the control arms on both the primary endpoint of time for discharge and on the key secondary endpoint of hospital length of stay.

In all cases, the key values were below 0.05 with hazard ratios north of two. It is important to note that the result far exceeded expectations given this was a small study with just 87 evaluated patients across the three arms. There were no serious adverse events associated with nitric oxide.

It's important to emphasize that the low dose of 85 parts per million NO had no effect when compared to placebo. We look forward to publishing the data just like the previous two pilot studies that have been published.

In our LungFit Home program, we are progressing rapidly towards initiating a multicenter 12-week, self-administered, at-home pilot study in 20 patients with nontuberculous mycobacteria lung infection. We expect to begin enrollment in the fourth quarter of 2020.

In order to be enrolled in the study, a patient needs to be diagnosed with either Mycobacterium abscessus complex, or M. abscessus, or Mycobacterium avium complex, or MAC. Patients will be titrated up to 250 parts per million nitric oxide. The study will evaluate safety, quality of life, physical function and bacterial load.

The FDA has emphasized the importance of quality of life improvement and physical function as well as an improved safety profile as markers of success versus sole indication of the bacteria. Based on our current expectations, we expect to report interim data from the at-home study around the end of the first half of calendar 2021.

As many of you are aware, we have a high confidence level for success in this study given our previously generated data. We're also quite encouraged by the simplicity of our LungFit system functionality. It's a simple 5-step process. First, plug the system into any standard electrical outlet. Turn on the power switch.

Insert the smoke filter into the system. Place the breathing mask on the face, and press the start button. This is a very straightforward system. Our smoke filters have an RFID chip that communicates with the system and will dictate the dosing parameters, so the patient does not have much to be concerned with.

As a reminder, LungFit automatically starts generating nitric oxide once the timer of the filter runs out. With a successful study, we believe our LungFit Home system opens the door of a very significant underserved market for chronic severe lung infections that can be treated in the home.

This market includes COPD patients with severe exacerbations that are frequently precipitated by an infectious agent. There are over one million hospitalizations annually in the United States due to exacerbations caused by lung infections in COPD patients, and we would look to avoid rehospitalization of these patients.

Clearly, this is quite a large unmet medical need. Finally, we turn to our solid tumor program. In June, we presented early but very promising data on colon and breast tumors in vitro and colon tumors in vivo. The data demonstrated a very potent antitumor activity with eradication in vitro and antitumor immunity in vivo.

We're very encouraged by this in vivo antitumor immunity, which was demonstrated with 25,000 to 200,000 parts per million nitric oxide in six mice versus 7 to 12 mice. Tumors grew in all seven control mice, while none of the six mice previously treated with nitric oxide for an initial tumor had a secondary tumor present.

We anticipate presenting more in vivo preclinical data before the end of this calendar year. With that, I will now turn the call over to Doug for the financial review.

Doug?.

Thank you, Steve. Here's a brief review of our financial results for the first quarter of fiscal year 2021, which ended on June 30, 2020. Revenue for the quarter was $229,000 as compared to $627,000 for the 3 months ended June 30, 2019.

All revenues related to the accounting for the payments made to Beyond Air will now be terminated commercial agreement for LungFit PH. Research and development expenses for the quarter were $4.3 million compared to $2.3 million for the 3 months ended June 30, 2019.

General and administrative expenses for the quarter were $2.5 million compared to $2.2 million for the three-month period June 30, 2019. For the quarter, the company had a net loss of $6.7 million or $0.40 per share compared to a net loss of $6.2 million or $0.67 per share for the same period last year.

As of June 30, 2020, the company had cash, cash equivalents and restricted cash of $24.4 million. This cash is sufficient to fund operations well beyond 12 months from today. I'll now hand it back to Steve..

Thanks, Doug. Before we go to the Q&A, I just want to point out that we have signed our commercial supply agreement with Spartronics, formerly Sparton, for the LungFit and LungFit PH systems. This is a critical step as we prepare to submit our PMA. Now on to questions.

Operator?.

We'll go ahead and take the first question from Suraj Kalia with Oppenheimer & Co..

So Steve, a lot of information provided on the call. Let me start out with the PMA submission dossier.

Between now and September 30, what still remains to be done to facilitate this time line, obviously, with the caveat that COVID is still somewhat of a wild card out there?.

Yes. So actually, there is testing to be done. We're wrapping up all different kinds of tests. And as you know, in a PMA, there's an enormous amount of documentation. So that's what's going on for the next roughly 8 weeks here, and it's a lot of work. And we have the people who can do it, and that's the time line that we are on.

So there are still some outside vendors who are working on us, and they're doing a fantastic job with us. And knock on wood, no impact from COVID, and we'll hit our time lines..

Got it. Steve, one of the things you mentioned on the call, which even ResMed was talking about yesterday, is potential long-term lung damage with COVID. And you also mentioned about COPD in a home-based setting, the potential for iNO use.

I guess, maybe you can help us understand what safety do you believe needs to be demonstrated in a home setting for this potential long-term use versus a PPHN, knowing that the latter one is ventilator compatible, so the form factor is different.

But just from a safety perspective in a home setting, what additional hurdles do you anticipate for the longer-term opportunity?.

So our study that we'll bring in nontuberculous mycobacteria patients will be self-administration at home. So we're going to get a good idea of what the profile in about 9 to 12 months when we share that data -- or at least the interim look at that data. So I think that the main hurdles are; one, NO2 safety.

We don't need nitrogen dioxide flooding someone's home. Obviously, our system has alarms, shutdown mechanisms. We have all kinds of safety precautions in place. We have timers on our system that shut down automatically. So if a patient falls asleep while taking the dose, it will stop manufacturing or producing nitric oxide by itself.

We have fail safes in place and safeguards in place. Obviously, with NO2 filtration, so there is no NO2 that's -- levels that are harmful. I think that's really the main issue is the NO2 levels, and we've taken extreme measures to make sure that it's safe not just in the home, but in the hospital as well for the LungFit and for the LungFit PH systems.

That's really probably the biggest hurdle in my opinion is the NO2. And then, of course, the user or the patient has to be able to understand how to handle the system. And as I described earlier in my prepared remarks, it's extremely simple. The filter runs the system.

So I really -- our team here has gone over this, I don't know, a couple of hundred times. The question you asked about what it needs to do to get home use, and it really comes back to NO2 levels. So just to wrap this question up, when our system is not in use, there's absolutely no danger of NO2. We don't store nitric oxide. It can't flip on by itself.

So when the system is not being used, even if it's plugged in, it's not being used, there's no danger. The only time, theoretically, there would be any concern is when the system is in operation, and the only way it can operate is with a filter in place.

So the filter is -- the purpose of the filter is to stop NO2 from reaching levels that are dangerous. And like I said earlier, we have alarms. We have fail safes in place. The system shuts down automatically and so forth. So I think the bottom line is NO2 is probably the biggest hurdle, and we don't really see it as a hurdle given our system.

But I think the hurdle is let's demonstrate it in a number of patients in their homes to regulatory authorities around the world that it is safe. So maybe a long-winded answer, I could have just said, too, but I wanted to give you the full picture..

No. Fair enough. And finally, Steve, and I will hop back in queue, the OUS partnership discussions for LungFit PH, what is the current status? Any time lines you can provide? Any thresholds you're looking to get over? Just some parameters and what -- if and what we could expect for PH..

Thanks, Suraj. There's really no time lines outside the U.S. that we want to get specific on at this time. I think Europe, being the big market outside the U.S., I think there's still some uncertainty about when the changes in the rules will take place.

That's obviously been delayed because of the pandemic, so there may be a window for us to get an approval before those changes are made. But we really have no visibility on that at the moment. It's still fairly chaotic. So I'm going to stay away from the kind of timing with partnerships ex U.S. at this time..

[Operator instructions] The next question is from Scott Henry with ROTH Capital..

I guess, starting with the COVID-19 program, when should we expect data from the Canadian trial?.

Thanks, Scott. I think data from the Canadian trial is going to do well after anything from the U.S. trial, so I wouldn't count on seeing 150 PPM data from the Canadian trial in the next 60 days like we've been targeted to get the U.S. trial ramped up.

So it's going to be a little bit longer than that for obvious reasons that they don't have as many cases as the U.S. does. So it's not very prevalent, which is good for Canada. So just not the volume of patients there to be able to get that done as quickly as we'd like..

Okay. And then with regards to the At-Home NTM trial, have you -- I guess, you described the data as interim by the end of -- or by the middle of 2021.

When would the long-term data there be? I assume all the interim data would cover the full data set with the primary endpoint, and we're looking at longer-term safety or just trying to get a sense of how we should think about that total package of data..

Yes. So the study is a 12-week treatment period with a 12-week follow-up period. So again, it's open-label, Scott, so we'll see how the data are coming in. But I would think that we'd like to show data interim look with patients who've completed the treatment phase. So once they've completed 12 weeks of treatment, we'd like to show something.

And depending on how enrollment goes, if we can get a bunch of patients that are well beyond that 12-week treatment period, get some follow-up, we'll decide when we want to put out that interim look. Since it is open label, we'll be seeing the data on a fairly regular basis.

But again, a full data set would be after the last patient has completed the 12-week follow-up period. So it should be no more than 4 to 6 months after the interim look roughly should be the final look. Again, I caution you that we may have to shut down sites and close them out and get reports written and so forth before we show the final dataset.

So I would say looking towards the next year -- in this calendar year, you'd be looking at the full dataset. So not too far beyond the interim look..

Okay. That's helpful. And then just on the income statement, so you're still bringing in these co-promote revenues.

Should this be the last quarter on the -- in the income statement or should some of that still linger in?.

Scott, I don't -- it's an accounting anomaly of how we recorded that deal, and it's not real cash. Let's say, it's GAAP accounting. So I want to refer to that question to Doug. I think there's one more quarter, but I -- honestly, Doug can answer that better.

Doug?.

That's really going through the performance obligations over through the filing of the -- when we get FDA approval. So it trickles in through that performance obligation when we get close to approval..

So Scott, it could be two or three more quarters is what Doug is saying. The numbers are small..

Yes, hardly makes a difference. Okay. And then on the R&D side, R&D kind of jumped up in Q1.

Should we expect that to continue? Or is that kind of a timing-related event?.

Yes, it's timing. I mean, in this quarter, we completely changed our bronchiolitis program into COVID, so there were some expenses to do that and trying to get that moving quickly. And there's also timing of payments to Spartronics for device manufacturing and so forth.

So it's guided to $4 million to $5 million per quarter, and I think that the last quarter was a little high. And I think that it will smooth out in the next quarter..

There was also a lot of noncash charges this quarter in -- of about $700,000 compared to the last quarter..

And the next question is from Matt Kaplan with Ladenburg Thalmann..

Just wanted to focus in on the LungFit PH PMA filing.

More specifically, can you talk a little bit about your commercial preparations that you're putting in place and how we should think about the initial launch in the second quarter if can you get approval?.

Well, Matt, for -- I keep saying it, we are preparing to launch this product on our own. We are still in discussions for potential partnership, so we'll keep along those parallel paths because there's no guarantee that the partnership discussions will end with a deal that's satisfactory to us. So we're prepared to launch the product ourselves.

And wherever it go, I mean, I think any of you who were at our Analyst Day in early March, you met our Chief Commercial Officer. He did have -- the presentation is fantastic, and we're all behind it. And we know we can launch the product alone without a problem. But there are factors that could lead us to partner as well.

So by the way, it will be launched in the second quarter of next year, pending FDA approval. And did you ask how we're going to launch it? I didn't catch the second half of that question, sorry..

Yes. And how are you going to launch that? Before -- previously, you described kind of a staggered or staged launch plan with it.

Is that still your objective here? Or what are your thoughts there?.

Yes. I think this is pretty classic for devices. I think it's -- especially in the hospital, I think you need to kind of just go slowly with a small percentage of the hospitals that are users of nitric oxide and can give you feedback, and I think that's what we'll do.

I think it's the right -- going out to 1,000-plus accounts at once is probably not the right method. So we will have that same strategy I've spoken about in the past, where it's a slow, controlled, step-wise launch..

And just one other question in relationship to the launch.

Can you talk about the manufacturing capacity that you'll have and the number of devices you think still have in place as you prepare to launch the product this year?.

Yes, we'll have -- given the slow trajectory in the first 6 to 9 months of the launch, we're going to have plenty of LungFit PH systems to the product within just a few weeks after we get approval. We're going to have a handful of systems that are commercially viable once we get to the PMA process, so I don't think capacity is an issue.

I think we can manufacture thousands of these systems a year with the line we have set up right now. So I'm not really worried about a U.S. launch. It's more so when we go international and start getting approvals outside the U.S. and picking up there that we may have to consider adding a second line.

But before that, one line that we have is more than sufficient for the U.S. market. As you know, there's probably less than 10,000 systems in the entire United States out there today, nitric oxide delivery systems, for the players that are over here in the market, so it's not intense on that side.

It's the filter that will be the key component that's used a lot in our systems, obviously. And the filters are very small. They're very simple to produce. We got more capacity than we would need. I think one line can do -- might not be able to do the world, I'm not sure yet, so we have to fill out just for PPHN.

If we get into other indications, that's when we have to start adding lines for the filters. So for PPHN, on the filter side, it's where [indiscernible] very easy to catch up if we get into a bind.

They also have -- again, them not being expensive and it's easy for us to keep inventory on hand, so I think the issue that you're thinking of with inventory and putting things into the supply chain, it's really a filter-related question, whereas the actual LungFit system itself, they'll be lasting five-plus years out in the market.

So we don't need a lot of them. So once we kind of get our foot in the door, it's really about the filters, and that's much, much easier supply chain to manage than the systems..

Great. That's very helpful. And then a few more questions, if I may.

You mentioned previously that the Canadian trial, as there are not as many patients in Canada to really get the 150 parts per million trial going and data going, have you thought about initiating the 150 parts per million study elsewhere in the world? And I know you were just contemplating at one point Israel.

And now with the resurgence there, is there a chance you could launch that study in Israel?.

Yes. Matt, Israel is probably the only place we can consider it because we can't send anybody anywhere. So if we try to do a study in another country outside of the U.S., Canada, because we do have people in Canada or Israel, we have nobody in those countries.

And we're not going to be shipping our LungFits to countries where we have no people, where they can't receive them from shipping and inspect them and configure them and train the people who are going to be using it.

This is not as simple as shipping a drug to a country and saying, "Here's -- just do it by mouth or do it by IV, where everybody understands how to do those things. Here this is a little bit different. So we are constrained to doing studies where we have people on the ground with COVID-19, and that really restricts us to just a few countries.

So that's the difficulty. I know there -- we get reports of COVID-19 around the world. In some countries where there's so much, we think it's just simple, snap your fingers, go there, study them.

It would be great if we can send people to those countries and bring them back here, but that's a nightmare to try to get your people to that country and then actually bring them back to the United States. So that's kind of a restriction on us at this moment in time. So we'll be working hard in the U.S. and, hopefully, as you know, going forward..

And then the solid tumor program, you announced some initial data already this year. What should we expect to see? You mentioned that there should be additional preclinical data for that program.

What should we expect to see there later this year? And then secondly, on the solid tumor program, can you paint a little -- a picture for us in terms of the path to IND and the path to the clinic in terms of in-human studies?.

So you're going to have to wait to see the data that we show. I think that we hope to show a different tumor than colon in vivo. We'll see if we have that for you. And could be some other data, we have to wait for some of these things to be completed and written up and presented. So I'm going to allude on that, Matt, and see what we present.

But as for the pathway to a first-in-man study, we're looking for that to happen about 12 to 15 months from now, so back half of next year, let's call it. I mean -- I don't know, September to December time frame next year looks like a reasonable target for us to do that. So we have a few more things to do.

As you can imagine, there's this volume of animals that needs to be tested. We have to choose which tumor type we'll be going with, the optimal tumor type to go with as our -- in our first advanced study. That decision hasn't been made yet. So we'll be doing some more testing on that.

And again, our -- I think I mentioned, too, we do have our own animal house, and that's been up and running for about a month. So it will take time to get that built and get all of those licenses in place for us to be able to start with our own animal house.

And that -- it's a big hurdle for us to get over, which gives us a lot of flexibility in terms of what we want to do and how we want to do it and the timing of when things can get done. So we really just started last month back up doing more in vivo studies. So I think that's all we can say at this moment in time..

And we'll take the next question from Yale Jen with Laidlaw..

I apologize for not coming early, so some of the things you might have mentioned, but I just want to follow up on that, which is that the -- for the COVID-19 on the press release, you indicated that the safety has been established.

So my question to you is that is the Canadian study started? And secondly, can that progress a little bit faster and jump to the 150 PPM for treating the patients? So any update on there?.

So the trial, we've not enrolled the patient yet there, so the trial has not begun. And we -- what we've put in the release and what I said in the prepared remarks, I was referring to the 80 parts per million study in the United States where we've -- was enrolled to date have seen a clean safety profile with respect to nitric oxide.

So that's all we stated. We didn't -- I hope it didn't imply anything about the Canadian study. It wasn't meant to, but we haven't gotten that study started yet..

Maybe to follow up a little more. In terms of the U.S. studies, you still need to go through the entire cohort before you can contemplate the next move or the data at this point could be sufficient to contemplate other sort of future path or future trials..

Well, yes, we've already contemplated our next move. That's for sure. We're just kind of waiting for sufficient supporting data to move ahead. So like you stated, I don't have the answer for you whether we need 10, 15 or 20 patients to be completed in our study before we can implement the next part of our strategy. I wish I knew the answer for you.

But you're right, it's a question that only time will tell what the answer is. This is something that, I guess -- I don't know if anybody can answer that question. So if we have to get to the full 20, then we'll get to the full 20. If we get -- stop at 16 or 14 or -- we will.

But again, it just depends on how -- what the data look like and what our next step is with FDA..

Two quick questions here.

The first one is that is there any updates in terms of the old data set for the U.S., whatever that number is? And the second is when the Canadian study is going to start?.

So with respect to the U.S., again, we're probably going to be talking with the FDA about the data at study before we have any kind of a press release on the data set. This is something that we, as company, want to work closely with FDA, not putting press releases out about every 2 or 3 patients that come into the study. That's not our goal.

Our goal is to use this information more closely with the FDA on how we can move forward. So I think you won't be seeing us putting out any press releases on any kind of data set for these patients until we share it with FDA first. So that will take care of the U.S. question.

And the Canadian question, it's a good question, when will we start? That's something we're debating internally, when we will start it or if we will. At this point, it's a matter of is it worth our resources to push forward in Canada.

Given what we know over the last couple of months since we got approved from Health Canada to run this study, we've pilot there. And we're deciding whether it's worthwhile for us to even entertain trying to get the study there.

And again, you have to understand the progress we've made in the U.S., what's going on in Israel and what we learned in Canada. So we have to put all these things together and make a strategic decision. So I can't answer your question because I don't know if we're going to try to start the study.

And if we do try to start the study, what that day would be, when that would actually start to enroll the first patient. So I'm sorry, I don't have an exact answer for you at the moment, but it's just not something that we made a decision on yet..

Okay. That's fine.

And I assume most of that probably depending on the infection rate in Canada or in the -- particularly in the near future, whether that will be suited -- or more suitable for starting the study there, right?.

Yes, yes. Those are the factors for sure..

And it appears there are no further questions at this time. Mr. Lisi, I'd like to turn the conference back to you for any additional or closing remarks..

Thank you, everyone, for joining and listening to our call today. Have a nice day..

That concludes today's call. Thank you for your participation. You may now disconnect..